Sofosbuvir/Velpatasvir in Postpartum Women With Opioid Use Disorder and Chronic Hepatitis C Infection

  • STATUS
    Recruiting
  • End date
    Jul 25, 2021
  • participants needed
    75
  • sponsor
    Elizabeth Krans, MD
Updated on 25 January 2021
hepatitis b
chronic hepatitis
sofosbuvir
velpatasvir

Summary

Incorporating HCV treatment into opioid maintenance treatment program clinical protocols is an innovative health care delivery model that has been associated with improved HCV treatment uptake in non-pregnant, drug-using populations. This "medical home" approach would combine HCV and opioid maintenance treatment into one treatment regimen and incorporate the expertise of obstetricians, hepatologists, substance abuse treatment providers and pediatricians into one comprehensive clinical care model. The purpose of this study is to evaluate the feasibility/acceptability of a combined, peripartum HCV and opioid maintenance treatment program on adherence to HCV treatment regimens and evaluate the rate of IVDU recidivism, HCV reinfection and health related QOL in women with OUD during the first postpartum year.

The protocol involves three separate study phases. All 3 study phases will occur with support from hepatology providers at Magee-Womens Hospital. Phase 1 involves screening, enrollment and a baseline assessment of liver function, HCV infection (genotype, viral load) and blood and urine studies in HCV-infected patients during pregnancy. In Phase 2, subjects will undergo 12 weeks of sofosbuvir/velpatasvir therapy initiated at 2 weeks postpartum. Feasibility/acceptability and adherence to sofosbuvir/velpatasvir will be assessed at 4, 8 and 12 weeks of therapy. In Phase 3, subjects will continue to be followed for 15 months after treatment completion. Treatment effectiveness and SVR will be evaluated at 3 months and rates of IVDU recidivism, HCV reinfection and patient centered outcomes such as health related quality of life (QOL) will be assessed at 6, 9 and 12 months following treatment completion.

Details
Condition Chronic viral hepatitis C, Opioid Use Disorder
Treatment sofosbuvir/velpatasvir
Clinical Study IdentifierNCT03057847
SponsorElizabeth Krans, MD
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you female?
Do you have any of these conditions: Opioid Use Disorder or Chronic viral hepatitis C?
Age 18 or older
Able and willing to provide written informed consent to be screened for and take part in the study procedures
Able and willing to provide adequate contact information
Chronic HCV, genotype 1 (1a, 1b), 2 (2a, 2b), 3, 4, 5, 6 infection, defined as a HCV antibody and detectable HCV RNA viral load at screening
Pregnancy at 28 + 0 to 37 + 6 weeks' gestation at enrollment with gestational dating confirmed by ultrasound
Documented negative Hepatitis B testing within 3 months prior to enrollment
Negative HIV testing within 3 months prior to enrollment
Per participant report at screening and enrollment, agrees not to participate in other research studies involving drugs or medical devices for the duration of study participation
Plans to deliver at Magee-Womens Hospital of University of Pittsburgh Medical Center (UPMC)

Exclusion Criteria

Participant report of any of the following at Screening or Enrollment
Previous treatment for Hepatitis C virus with a sofosbuvir based regimen
Use of any medications contraindicated with concurrent use of sofosbuvir/velpatasvir according to the EPCLUSA package insert
Plans to relocate away from the study site area in the next 18 months
Current sexual partner is known to be infected with HIV or Hepatitis B virus
History of decompensated cirrhosis (history of variceal bleed, ascites or hepatic encephalopathy)
Reports participating in any other research study involving drugs or medical devices within 60 days or less prior to enrollment
Ongoing illicit drug use evidenced by positive urine drug screen with appropriate confirmatory testing for anything other than marijuana since the first prenatal visit that cannot be explained by a prescribed medication
Breastfeeding or pumping and feeding infant breastmilk
At screening or enrollment, as determined by the Protocol Chair, any significant uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder or infectious disease (other than Hepatitis C)
Has any of the following laboratory abnormalities at Screening
Aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 10 times the upper limited of normal
Hemoglobin less than 10 g/dL
Platelet count less than 90,000 per mm3
International normalized ratio (INR) > 1.5
GFR < 40
Has any other condition that, in the opinion of the IoR/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives
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